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NCT Number: NCT07255482

Mortality Benefit of Ultrasound for Thyroid Nodules Identified With PET Imaging: Non-Inferiority Emulated Target Trial

The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. That is, among patients with an incidental thyroid nodule on PET-CT, mortality is no more than 5% larger (in absolute difference) for those who do not have thyroid ultrasound compared to those who do. The investigators will also report mortality differences at landmark timeframes of 1-year, 3-years, 5-years, and 10-years. To estimate group differences in mortality, the investigators will conduct a non-inferiority emulated target trial utilizing clone-censor weighting to address potential immortal time bias introduced by the 3-month grace period. The investigators will adjust for demographic, potential confounder, and mortality risk adjustor factors. The investigators will stratify analyses based on baseline disease severity (estimated 5-year relative survival risk) and disease status (progression, lymph node involvement, other sites of metastases). All subjects will be accrued from the Mass General Brigham healthcare system, which includes two academic medical centers, a specialty head and neck hospital, and multiple community hospitals and numerous community clinics.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Thyroid Nodule (Benign) Disease Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Thyroid Nodule Thyroid Nodule (Diagnosis)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

Study Hypothesis: The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound within 3 months is no worse than 5% lower than those who did have ultrasound.

Outcome Measures:

Primary Outcome: All-cause mortality. Secondary Outcomes: Numbers of thyroid cancer diagnoses, thyroid ultrasounds, thyroid biopsies, and thyroid surgeries Exploratory Outcomes: Types of thyroid cancer diagnoses

Study Population: All patients age 18-years and older with incidental thyroid nodule on PET-CT performed between 1/1/2015 and 12/31/2021.

Sites/Facilities: Mass General Brigham healthcare system including Massachusetts General Hospital, Brigham and Women's Hospital, Mass Eye and Ear, and associated community sites.

Exposure: Thyroid ultrasound evaluation within 3-months of PET-CT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >=18
  • Thyroid nodule on PET-CT performed 1/1/2015 to 12/31/2021
  • At least one clinical note in the EHR from the 36-month window prior to the PET

Exclusion criteria

  • Thyroid ultrasound listed in the medical record in the prior 3 years
  • Documented history of prior thyroid cancer diagnosis

Treatment and study plan

Thyroid ultrasound

Diagnostic Test

Thyroid ultrasound performed within 3 months of PET to characterize a thyroid nodule identified on the PET

Primary outcomes

  1. All-Cause Mortality

    Time frame: 7 Years

Secondary outcomes

  1. Number of Thyroid Cancer Diagnoses

    Time frame: 7 Years

  2. Number of Thyroid Ultrasound Examinations

    Time frame: 7 Years

  3. Number of Thyroid Biopsies

    Time frame: 7 Years

  4. Number of Thyroid Surgeries

    Time frame: 7 Years

Other outcomes

  1. Types of Thyroid Cancers

    Time frame: 7 Years

    Exploratory

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Harvard School of Public Health (HSPH)

Registry information

Official study title

Mortality Benefit of Ultrasound for Incidental Thyroid Nodules Identified With PET Imaging: A Non-Inferiority Emulated Target Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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